Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With NAFLD

Overview

The study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD

Full Title of Study: “Effect of Multi Vitamin and Mineral Supplementation of Liver Enzymes and Sonography in Patient With Non-alcoholic Fatty Disease (NAFLD); RCR”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Study Primary Completion Date: May 2, 2023

Detailed Description

This study was performed on 160 participants, to ensure the impact of multi vitamin and mineral to reduce NAFLD. Participants were randomly selected to participate in the study. Then divided into the groups (intervention and placebo). Intervention received supplementation for 12 weeks and placebo received same capsule was made for placebo groups.

Interventions

• Combination Product: Multiviamins and minerals
  • The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
• Combination Product: Placebo
  • Placebo

Arms, Groups and Cohorts

• Experimental: effect multivitamin and minerals on NAFLD for 12 weeks
  • The intervention group received one capsule of multivitamin and minerals supplements every day, one hour after breakfast, for 12 weeks.
• Placebo Comparator: Placebo
  • the control group took a placebo prepared with the same shape and size of supplements.

Clinical Trial Outcome Measures

Primary Measures

• Multivitamin and minerals supplementation has role in reduce liver enzymes
  • Time Frame: 12 weeks
  • Multivitamin and minerals supplement was given for 12 weeks and has role in reduce Serum Bilirubin, alkaline phosphatase (ALP), alanine transaminase (ALT), and liver enzyme was measured by blood sampling tests.

Participating in This Clinical Trial

Inclusion Criteria

• Participants with NAFLD diagnosed Exclusion Criteria:

• subjects who in the last 6 months received vitamin or mineral supplementation, those with chronic conditions such as diabetes, hypertension, and heart disease, unwillingness to continue the study protocol, lactating women and pregnant women.

Gender Eligibility: All

Minimum Age: 22 Years

Maximum Age: 78 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Sulaimany Polytechnic university
• Provider of Information About this Clinical Study
  • Principal Investigator: Hawal Lateef Fateh, Dr Hawal Lateef Fateh – Sulaimany Polytechnic university
• Overall Official(s)
  • HAWAL F Lateef, Msc, Principal Investigator, Nursing Department, Kalar Technical College, Sulaimani polytechnic university, Sulaimani, Iraq